UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058452 |
|---|---|
| Receipt number | R000066830 |
| Scientific Title | The Synergistic Biomarker 50kHz Reactance and Walkability Score as a Revolutionary Predictor of Behavioral Change and Glycemic Control in Primary Care Diabetes Management - A Retrospective Cohort Study |
| Date of disclosure of the study information | 2025/07/14 |
| Last modified on | 2025/07/14 04:57:44 |
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Basic information
Public title
Development and Validation of a Predictive Index for Glycemic Control by Trends in Environmental Factors and Body Composition in Patients with Type 2 Diabetes Mellitus
Acronym
Development of a Predictive Index of Glycemic Control by Environmental Factors and Body Composition in Patients with Type 2 Diabetes Mellitus
Scientific Title
The Synergistic Biomarker 50kHz Reactance and Walkability Score as a Revolutionary Predictor of Behavioral Change and Glycemic Control in Primary Care Diabetes Management - A Retrospective Cohort Study
Scientific Title:Acronym
A Retrospective Cohort Study of Behavior Change Prediction and Glycemic Control in Patients with Newly Diagnosed Type 2 Diabetes Mellitus
Region
| Japan |
Condition
Condition
Type 2 Diabetes Mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To develop and validate a synergistic behavioral prediction index (SBPI) combining 50 kHz reactance and neighborhood walking environment scores in newly diagnosed type 2 diabetic patients to assess its predictive accuracy for successful behavior change and achievement of glycemic control in lifestyle interventions.
Basic objectives2
Others
Basic objectives -Others
Evaluation of the single predictive ability of bioelectrical impedance-derived body composition indices and analysis of the effect modifying effect of environmental factors (walking environment), and effect estimation after adjustment for selection bias using causal inference methods.
Trial characteristics_1
Others
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Achieve good glycemic control (HbA1c <7.0%) after 4 months
Key secondary outcomes
HbA1c change Body composition change (50 kHz reactance, muscle mass, body fat percentage) Muscle strength index change Composite body composition index change Intervention adherence
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Food | Behavior,custom | Other |
Interventions/Control_1
Standardized lifestyle intervention (dietary therapy + exercise therapy + education)
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Newly diagnosed type 2 diabetes (within 3 months of diagnosis) Age 20-80 Baseline HbA1c 6.5-9.9% (48-85 mmol/mol) Available to participate in lifestyle intervention
Key exclusion criteria
Type 1 diabetes or secondary diabetes Pregnant or lactating Serious liver disease (ALT >3 times upper limit of normal) Heart failure (NYHA Class III-IV) Dialysis or eGFR <30 mL/min/1.73m^2 Contraindication to bioelectrical impedance measurement Not obtain informed consent
Target sample size
195
Research contact person
Name of lead principal investigator
| 1st name | Akira |
| Middle name | |
| Last name | Kimura |
Organization
Gunma Paz University
Division name
Department of Rehabilitation Sciences
Zip code
3700006
Address
Tonyamachi1-7-1,Takasaki,Gunma, Japan
TEL
027-365-3366
kimuaki@nifty.com
Public contact
Name of contact person
| 1st name | Akira |
| Middle name | |
| Last name | Kimura |
Organization
Gunma Paz University
Division name
Department of Rehabilitation Sciences
Zip code
3700006
Address
1-7-1 Tonyamachi,Takasaki,Gunma
TEL
027-365-3366
Homepage URL
https://kimuakilabo.main.jp/kaken2024-2026-1.html
kimuaki@nifty.com
Sponsor or person
Institute
Gunma Paz University
Institute
Department
Personal name
Akira Kimura
Funding Source
Organization
Gunma Paz University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
ethics committee, Gunma Paz University
Address
1-7-1 Tonyamchi, Takasaki, Gunma
Tel
027-365-3366
akimura753@gmail.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Select One
Institutions
Institutions
済生会前橋病院（群馬県）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 07 | Month | 14 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
195
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
Because of the COVID19 epidemic, the previous routine was no longer possible.
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 06 | Month | 20 | Day |
Date of IRB
| 2023 | Year | 06 | Month | 20 | Day |
Anticipated trial start date
| 2022 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 01 | Month | 15 | Day |
Date trial data considered complete
| 2024 | Year | 02 | Month | 01 | Day |
Date analysis concluded
| 2024 | Year | 04 | Month | 02 | Day |
Other
Other related information
Management information
Registered date
| 2025 | Year | 07 | Month | 14 | Day |
Last modified on
| 2025 | Year | 07 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066830
